Background
Patients with advanced or metastatic esophageal cancer of squamous cell type have poor prognosis. For these patients, treatment options are limited after first therapy.
Tislelizumab is a humanized monoclonal antibody directed against PD-1. It prevents PD-1 from binding to the ligands PD-L1 and PD-L2. It is being investigated as a treatment for advanced cancers.
Purpose of the RATIONALE-302 Study
Evaluate Tislelizumab versus chemotherapy as second treatment for advanced or metastatic esophageal cancer of squamous cell type (RATIONALE-302): A randomized phase III study.
The primary end point was Survival in all patients.
The secondary end point was Survival in patients with PD-L1 tumor area positivity (TAP) score ≥ 10%.
Patients and Methods
In this phase III clinical study, patients with advanced or metastatic esophageal squamous cell carcinoma, whose tumor progressed after first systemic treatment, were randomly assigned to receive Tislelizumab or chemotherapy (investigator’s choice of Taxol, Taxotere, or Irinotecan).
Results
In total, 512 patients were recruited.
At final analysis, the Survival was significantly longer with Tislelizumab versus chemotherapy in all patients (8.6 vs 6.3 months) and the risk of death decreased by 30%
In patients with TAP ≥ 10%, the Survival was 10.3 vs 6.8 months and the risk of death decreased by 46%.
Treatment with Tislelizumab was associated with higher response rate (20.3% vs 9.8% of patients who experienced disease control and/or decrease in lesion volume due to the treatment) and a more durable antitumor response (7.1 vs 4.0 months) in all patients.
Fewer patients experienced harsh treatment-related side effects (18.8% vs 55.8%) with Tislelizumab versus chemotherapy.
Conclusion
Tislelizumab significantly improved Survival compared with chemotherapy as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma.
Tislelizumab demonstrated a tolerable safety profile.
Patients with PD-L1 TAP ≥ 10% also demonstrated significant Survival benefit with Tislelizumab versus chemotherapy.
Take-Home Message
These findings suggest that Tislelizumab is an effective and safe therapy in patients with advanced or metastatic ESCC after progression on first-line therapy and should be considered in this patient population.
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